Byetta + Lantus Improved Outcomes without Weight Gain or Hypoglycemia

Amylin and Eli Lilly announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTAA® (exenatide) injection added to Lantus® (insulin glargine)…. 

This study showed patients with Type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia. In the study, patients receiving insulin glargine, with or without oral agents, were randomized to receive BYETTA or placebo in addition to aggressive insulin titration. After 30 weeks of treatment, A1c decreased by 1.7 percentage points in patients adding BYETTA, compared with a decrease of 1.0 percentage point in patients treated with insulin alone. Weight decreased in patients adding BYETTA by 4 pounds, compared with an increase of 2 pounds in patients treated with insulin alone. Fasting plasma glucose and hypoglycemia were similar between treatment groups.  

“Even in this population of patients who were poorly controlled on insulin therapy, the addition of BYETTA to optimized basal insulin therapy provided exactly what we hoped for. Improved control of blood sugar throughout the day, weight loss and no increased risk of hypoglycemia as compared to optimized basal insulin treatment alone,” said John Buse, M.D., Ph.D., Professor of Medicine, Director of the Diabetes Care Center, and Chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill. “This study showed BYETTA may provide a complementary addition to basal insulin for these hard-to-treat Type 2 diabetes patients.”

Results from this study will form the basis for a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA). The filing is planned for the end of 2010.

The double-blind, placebo-controlled study enrolled 261 patients (mean age: 59 years old; weight: 208 pounds; A1c: 8.4 percent; diabetes duration: 12 years; insulin dose: 48 units) who were randomized to BYETTA 10 micrograms (n=137) or placebo (n=122). Groups were generally comparable at baseline. Insulin dose was decreased by 20 percent if a patient’s A1c was < 8 percent or maintained if a patient’s A1c was > 8 percent for five weeks, then titrated to achieve a target fasting glucose of < 100 mg/dL. Primary endpoint was change in A1c, a measure of average blood sugar over three months. Continuous glucose monitoring (n=23) and 7-point glucose profiles demonstrated significant postprandial effects with BYETTA compared with insulin alone. Insulin dose increased more in the placebo group (20+2 units) than in the BYETTA group (13+2 units) to achieve the fasting glucose target.

Amylin and Eli Lilly Press Release